Pelvic implant system and method

ABSTRACT

Systems and methods are provided and adapted to engage and pull (e.g., pull up) or reposition paraurethral support tissue, such as the perineal membrane. The perineal membrane intersects the urethra and vagina at the midurethra or distal location and can thus be stabilized or controlled in a manner that helps restore continence. As such, the implants can be utilized to eliminate the need for mesh or other supportive structures under the urethra that is common with other incontinence slings.

PRIORITY

This application claims priority to and the benefit of U.S. ProvisionalPatent Application No. 61/510,726, filed Jul. 22, 2011, U.S. ProvisionalPatent Application No. 61/515,180, filed Aug. 4, 2011, U.S. ProvisionalPatent Application No. 61/545,104, filed Oct. 7, 2011, U.S. ProvisionalPatent Application No. 61/547,467, filed Oct. 14, 2011, U.S. ProvisionalPatent Application No. 61/547,503, filed Oct. 14, 2011, U.S. ProvisionalPatent Application No. 61/607,332, filed Mar. 6, 2012, U.S. ProvisionalPatent Application No. 61/607,891, filed Mar. 7, 2012, U.S. ProvisionalPatent Application No. 61/608,436, filed Mar. 8, 2012, U.S. ProvisionalPatent Application No. 61/608,478, filed Mar. 8, 2012, U.S. ProvisionalPatent Application No. 61/653,199, filed May 30, 2012, U.S. ProvisionalPatent Application No. 61/653,213, filed May 30, 2012, U.S. ProvisionalPatent Application No. 61/653,224, filed May 30, 2012, and U.S.Provisional Patent Application No. 61/653,236, filed May 30, 2012; witheach of the above-referenced applications and disclosures incorporatedherein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to apparatus, tools and methods fortreating pelvic conditions and, more particularly, systems and methodsto support pelvic tissue by acting on, stabilizing, positioning orcontrolling the position of the perineal membrane or like anatomicalstructures.

BACKGROUND OF THE INVENTION

It has been reported that over 13 million American men and women of allages suffer from urinary and fecal incontinence. The social implicationsfor an incontinent patient include loss of self-esteem, embarrassment,restriction of social and sexual activities, isolation, depression and,in some instances, dependence on caregivers. Incontinence is the mostcommon reason for institutionalization of the elderly.

The urinary system consists of the kidneys, ureters, bladder andurethra. The bladder is a hollow, muscular, balloon-shaped sac thatserves as a storage container for urine. The bladder is located behindthe pubic bone and is protected by the pelvis. Ligaments hold thebladder in place and connect it to the pelvis and other tissue. Theurethra is the tube that passes urine from the bladder out of the body.The narrow, internal opening of the urethra within the bladder is thebladder neck. In this region, the bladder's bundled muscular fiberstransition into a sphincteric striated muscle called the internalsphincter. The urethra extends from the bladder neck to the end of thepenis. The male urethra is composed of three portions: the prostatic,bulbar and pendulus portions. The prostatic portion is the widest partof the tube, which passes through the prostate gland. The rectum is themost distal portion of the gastrointestinal tract. The exterior openingof the rectum is the anus. Fecal continence is related to control of theexterior sphincter and interior sphincter of the anus.

Urinary incontinence may occur when the muscles of the urinary systemare injured, malfunction or are weakened. Other factors, such as traumato the urethral area, neurological injury, hormonal imbalance ormedication side-effects, may also cause or contribute to incontinence.There are five basic types of incontinence: stress incontinence, urgeincontinence, mixed incontinence, overflow incontinence, and functionalincontinence. Stress urinary incontinence (SUI) is the involuntary lossof urine that occurs due to sudden increases in intra-abdominal pressureresulting from activities such as coughing, sneezing, lifting,straining, exercise and, in severe cases, even simply changing bodyposition. Urge incontinence, also termed “hyperactive bladder,”“frequency/urgency syndrome,” or “irritable bladder,” occurs when anindividual experiences the immediate need to urinate and loses bladdercontrol before reaching the toilet. Mixed incontinence is the mostcommon form of urinary incontinence. Inappropriate bladder contractionsand weakened sphincter muscles usually cause this type of incontinence.Mixed incontinence is a combination of the symptoms for both stress andurge incontinence. Overflow incontinence is a constant dripping orleakage of urine caused by an overfilled bladder. Functionalincontinence results when a person has difficulty moving from one placeto another. It is generally caused by factors outside the lower urinarytract, such as deficits in physical function and/or cognitive function.

SUI is generally thought to be related to hypermobility of the bladderneck or an intrinsic urethral sphincter defect. A variety of treatmentoptions are currently available to treat incontinence. Some of thesetreatment options include external devices, behavioral therapy (such asbiofeedback, electrical stimulation, or Kegal exercises), injectablematerials, prosthetic devices and/or surgery. Depending on age, medicalcondition, and personal preference, surgical procedures can be used tocompletely restore continence.

Conservative management of SUI can include lifestyle changes, such asweight loss, smoking cessation, and modification of intake of diureticfluids such as coffee and alcohol. Midurethral slings have beeneffective. One type of procedure, found to be an especially successfultreatment option for SUI in both men and women, is a sling and supportprocedure.

A sling procedure is a surgical method involving the placement of asling to stabilize or support the bladder neck or urethra. There are avariety of different sling procedures. Slings used for pubovaginalprocedures differ in the type of material and anchoring methods. In somecases, the sling is placed under the bladder neck and secured viasuspension structures or sutures to a point of attachment (e.g., tissueor bone) through an abdominal and/or vaginal incision. Examples of slingprocedures are disclosed in U.S. Pat. Nos. 5,112,344; 5,611,515;5,842,478; 5,860,425; 5,899,909; 6,039,686, 6,042,534, 6,110,101,6,911,003, 6,652,450, and International PCT Publication No. 2008/057261,all of which are herein incorporated by reference in their entirety.

Fecal incontinence, like urinary incontinence, has proven to bechallenging to treat. Patients whose fecal incontinence is caused byexternal anal sphincter injury is treated surgically, as with asphincteroplasty. Other patients, though, are considered to haveneurogenic or idiopathic fecal incontinence, and efforts to treat thesepatients has been less successful. Various procedures, such as postanalrepair, total pelvic floor repair, muscle transposition techniques,dynamic graciloplasty, artificial sphincter procedures, and sacral nervestimulation. Success has been limited, and the various treatmentmodalities can result in morbidity.

There is a desire for a minimally invasive yet highly effectivetreatment modality that can be used with minimal to no side effects forthe treatment of both urinary and fecal incontinence. Such a modalityshould reduce the complexity of a treatment procedure, be biocompatible,should reduce pain, operative risks, infections and post operativehospital stays, and have a good duration of activity. Further, themethod of treatment should also improve the quality of life forpatients.

SUMMARY OF THE INVENTION

The present invention can include surgical instruments, implantablearticles, and methods for urological applications, particularly for thetreatment of stress and/or urge urinary incontinence, fecalincontinence, and prolapse by implanting a paraurethral constrainingdevice. The constraining device or implant can control and eliminaterotation of the urethra that is associated with incontinence.

Embodiments of the present invention can include apparatus and methodsfor treating urinary incontinence, fecal incontinence, and other pelvicdefects or dysfunctions, in both males and females using one or moreimplants to reinforce the supportive tissue of the urethra. The implantsare configured to engage and pull (e.g., pull up) or reposition thesupportive tissue, such as the perineal membrane. The perineal membraneis the fibrous membrane in the perineum that intersects the urethra andvagina near the midurethra location and can thus be stabilized orcontrolled in a manner that helps restore continence. As such, systems,methods and implants can be utilized to eliminate the need for mesh orother supportive structures under the urethra that is common with otherincontinence slings. The implants can be shaped to facilitate suchsupport, e.g., provided with anchoring end portions, barbs or otherdevices of many available shapes and configurations. One or more anchorsor tissue engagement portions can be employed to attach and stabilizethe implants or devices to tissue.

Embodiments of the present invention can provide smaller implants ordevices, fewer implant or device components, thus reducing the size andnumber of incisions, improving implant manipulation and adjustment, thecomplexity of the insertion and deployment steps, and healing times.

The implants can resist movement of tissue such as, for example, forwardrotational movement of the urethra or surrounding tissue. The presentimplant embodiments can utilize a perineal incision or puncture and aparaurethral constraining device. Alternatively, the device may beimplanted transvaginally.

In certain embodiments, one or more paraurethral support devices areprovided. Paraurethral suspension elements are provided for thetreatment of SUI and other disorders. The support, extension orsuspension elements can apply mechanical traction to the urethra in amanner similar to a mini-sling device, wherein tension is applied at themidurethral position to lift and support that anatomical structureduring stress events, such as coughing or physical activity.

An anchoring element or portion, such as a medial or proximal anchor, isfixed on each side of the urethra on the far side of a tissue layer thatis known to have relatively high strength and toughness. Such anatomicalstructures can include the uterovaginal fascia, endopelvic fascia,perineal membrane or other anatomical features at which connectivesupport of the urethra can be established. The medial anchor can includea self-expanding anchor, a “toggle” anchor, which is a small elongatedstructure that can be placed through the tissue via a small puncture orlike incision and then rotates after deployment so that it cannot backout through the incision hole, or a myriad of other anchoring and tissueengagement devices.

Placing the medial anchor device on the far side of the fascia isadvantageous because it is less likely to be palpable than one placed inthe mucosal and muscle layer. It can be placed in an area of looseconnective tissue in which the anchor can easily rotate or expand into alocking or engaging orientation.

A second anchor device, such as a distal anchor or engagement device, isplaced in a lateral or superior position such that a connection betweenthe medial and lateral anchors (via a suture, mesh, wire or likeconnection) can provide tensile support for the urethra during stressevents. The distal anchor device can be fixated to, or around, thetendinous arch of the levator ani (white line), the Cooper's ligament,the obturator foramen, obturator internus, abdominal fascia,sacrospinous ligament, prepubic fascia or muscle, the pubic symphysiscartilage, or other stable anatomical structures. The distal anchordevices can include a body portion, a beveled tip, one or moreexpandable barbs, a thru-aperture, and an opposing end. The suture orlike extension member is adapted to string or thread through therespective apertures of a series or array of such anchors. The array ofanchors can be inserted within and along the interior lumen of a needle,cannula or like inserter or delivery tool for deployment. In addition,the distal anchor, or anchor array, can be directed down below theurethra for fixation, to provide an alternate control over the positionand rotation of the urethra.

The final position of the implanted device creates a support structurethat can include a generally straight, suspension orientation. Themedial anchor can spread or better distribute the tension load over alarger surface compared to a thin suture cutting edge surface. This, inturn, promotes stability of the anchor and connecting suture and,ultimately, the target support tissue.

Various procedural steps or methods can be implemented to deploy andanchor the implant of the present invention. In one embodiment, themedial anchor is implanted, a needle is withdrawn, a free suture orconnector end is delivered through the insertion opening, the seconddistal anchor is delivered and implanted, and the connecting suture isproperly tensioned between the anchors to provide proper support. Thesuture or other support extensions members can be constructed to begenerally flexible, or to have limited elasticity—e.g., bungee-typeattributes.

Various anchoring systems, device, techniques and placement locationsare provided to facilitate the support and rotational prevention ofexemplary embodiments, as well as hingable anchor constructs andconfigurations, as well as suture pathways and anchoring positions.

A benefit of certain embodiments of the present invention is that atransvaginal placement of the support devices does not leave exposedmaterial inside the vaginal cavity. For example, the final deviceposition can be completely blind, beyond the superficial mucosal layerof the vaginal wall. Reducing or eliminating the exposed materialminimizes the risk of infection, irritation at the surface of thevaginal wall, and provides cosmetic improvement and reduces interferencewith sexual activity.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of various anatomical structures of thefemale pelvic region, including urinary and reproductive systems.

FIGS. 2-6 are schematic views of various anatomical structures of thefemale pelvic region, and bilateral implants having medial and lateralanchors, in accordance with embodiments of the present invention.

FIG. 7 shows a side view of an implant system having medial and lateralanchors, and sutures, in accordance with embodiments of the presentinvention.

FIG. 8 is a top view of an implant system having medial and lateralanchors, in accordance with embodiments of the present invention.

FIG. 9 is a perspective view of a distal anchor/barb in accordance withembodiments of the present invention.

FIG. 10 is a partial sectional view of the distal anchor/barb of FIG. 9.

FIG. 11 is a side schematic view of a distal anchor array and suturewithin a delivery needle device, in accordance with embodiments of thepresent invention.

FIG. 12 is a side view of a distal anchor array and suture deployed froma delivery needle device, in accordance with embodiments of the presentinvention.

FIG. 13 is a perspective view of a distal anchor array and suture withina slotted needle device, in accordance with embodiments of the presentinvention.

FIG. 14 is a side schematic view of a distal anchor array and suturewithin a slotted needle device, in accordance with embodiments of thepresent invention.

FIG. 15 is a side view of a distal anchor array and suture deployed froma slotted needle device, in accordance with embodiments of the presentinvention.

FIG. 16 is a side view of a distal anchor array and suture at leastpartially tensioned, in accordance with embodiments of the presentinvention.

FIG. 17 is a perspective view of a distal anchor array and dual suture,in accordance with embodiments of the present invention.

FIG. 18 is a perspective view of a distal anchor/barb in accordance withembodiments of the present invention.

FIG. 19 is a side view of distal anchor array and suture in a collapsedstate, in accordance with embodiments of the present invention.

FIG. 20 is a side view of a distal anchor array and suture in anexpanded state, in accordance with embodiments of the present invention.

FIG. 21 is a side view of a distal anchor array and suture, showingexemplary load and moment data, in accordance with embodiments of thepresent invention.

FIG. 22 is a perspective schematic view of a distal anchor array, withdual barbs, and a suture partially within a needle device, in accordancewith embodiments of the present invention.

FIG. 23 is a perspective view of a distal anchor, or anchor portion,having dual barbs, in accordance with embodiments of the presentinvention.

FIG. 24 is a side schematic view of a medial anchor and suture within adelivery tube or oversleeve, in accordance with embodiments of thepresent invention.

FIG. 25 is a sectional schematic view of a medial anchor and suturewithin a delivery tube or oversleeve, in accordance with embodiments ofthe present invention.

FIG. 26 is a side schematic view of a medial anchor and suture, with themedial anchor expanded and deployed from a delivery tube or oversleeve,in accordance with embodiments of the present invention.

FIG. 27 is a perspective schematic view of a medial anchor and suture,with the medial anchor expanded and deployed from a delivery tube oroversleeve, in accordance with embodiments of the present invention.

FIGS. 28-30 are schematic views of various anatomical structures of thefemale pelvic region, and an implant system having medial and lateralanchors, and the deployment method, in accordance with embodiments ofthe present invention.

FIGS. 31-38 are schematic views of paraurethral implant systems andmethods, with a suture or extension member interwoven or thread throughtissue, in accordance with embodiments of the present invention.

FIG. 39 is a schematic view of a coil spring device operably connectedto one or more of anchors for use in an implant system and method inaccordance with embodiments of the present invention.

FIG. 40 is a schematic view of tissue engagement devices for a medialanchor, in accordance with embodiments of the present invention.

FIGS. 41-42 are schematic views of a dilating medial anchor device inaccordance with embodiments of the present invention.

FIGS. 43-45 are schematic views of a grasping medial anchor device, andimplantation method, in accordance with embodiments of the presentinvention.

FIGS. 46-47 are views of a generally star-shaped medial anchor device,in accordance with embodiments of the present invention.

FIGS. 48-54 are schematic views of a suture and cinch device implant, inaccordance with embodiments of the present invention.

FIG. 55 is a schematic view of various anatomical structures of thefemale pelvic region, and an implant system having medial anchors,lateral anchors, and crossing extension members, in accordance withembodiments of the present invention.

FIG. 56 is a schematic view of an implant system having suture anchorsin the perineal membrane, in accordance with embodiments of the presentinvention.

FIG. 57-62 are schematic views of an anchor and needle introductionsystem for use with embodiments of the present invention.

FIGS. 63-67 are partial schematic sectional views of a tissue separationdevice for use with embodiments of the present invention.

FIG. 68 is a schematic view of a suture locking device for use withembodiments of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1 shows a schematic view of relevant portions of the female pelvicregion, and the urinary and reproductive system, including the pelvisPE, vagina V, uterus UT, urethra U, bladder B and the deep clitoral veinC. Further, a portion of the perineal membrane PM is shown at themidurethra/distal location, providing a viable paraurethral target forstabilizing or controlling the position and movement of the urethra toassist in restoring continence.

Embodiments of the present invention can include apparatus and methodsfor treating urinary incontinence, fecal incontinence, and other pelvicdefects or dysfunctions, in both males and females using one or morelateral implants to reinforce the supportive tissue of the urethra. Oneor more implant devices 10 are configured to engage and pull (e.g., pullup) or reposition support tissue (e.g., paraurethral), such as theperineal membrane, uterovaginal fascia, endopelvic fascia, or otheranatomical features at which connective support of the urethra can beestablished. The perineal membrane intersects the urethra and vagina atthe midurethra/distal location and can thus be stabilized or controlledin a manner that helps restore continence. As such, the implants 10 canbe utilized to eliminate the need for mesh or other supportivestructures under the urethra that is common with other incontinenceslings. The implants can be shaped to facilitate such support, e.g.,provided with anchoring end portions 12, barbs or other devices of manyavailable shapes, sizes and configurations, and extension members 30.

Various embodiments of the extension members 30 can be constructed of asuture, a thin flat member, braided fibers, braided nano-fibers, anelongate mesh and other various materials and constructs. For thoseembodiments including braided nano-fibers, the extension member 30 canenhance and draw more collagen-producing cells to the material topromote tissue ingrown and healing. The extension member 30 of certainembodiments of the present invention can be constructed to be generallyflexible, or to have limited elasticity—e.g., bungee type attributes.For instance, the member 30 extending between the anchors 14 and anchors16 can be an elongate member constructed of an elastomeric materialhaving desirable tensile properties. As such, the member 30 can bestretched out for deployment and then released to provide desirable tauttension. The travel or stretching/rebound characteristics of the member30 can vary depending on the particular elastomeric materials used inits construction. The extension member 30, such as a suture, can furtherinclude various extending tines or barbs to facilitate the tissuetraction and grabbing during and after deployment.

One or more opposing anchors 14, 16 or tissue engagement portions can beemployed to attach and stabilize the implants to the tissue, as well asprovide selective adjustment. The anchors or engagement portions can beconfigured to engage soft tissue and can include various barbs, tines,serrated edges, extending fibers, or other similar structural feature topromote tissue fixation. The anchors can be implanted in a directionlateral from the urethra. The anchors can generally be small enough forto be unnoticeable by both the patient and the patient's sexual partner.The anchors and other devices and components of the system 10 may beconstructed from various biocompatible materials, such as known polymersand metals that promote long-term resilience, or other materials knownto those skilled in the art.

In various embodiments, the one or more implants 10 can be placed instrategically located positions to pull up or otherwise tighten tissueand/or muscle lateral or otherwise intersecting or attached (directly orindirectly) with the urethra to generally stabilize the anatomicalstructure of the patient. Various systems, devices, structures,techniques and methods, alone or in combination, as disclosed in U.S.Pat. Nos. 7,500,945, 7,407,480, 7,351,197, 7,347,812, 7,303,525,7,025,063, 6,911,003, 6,691,711, 6,648,921, 6,612,977, 6,802,807,2002/0161382, 2002/0147382, 2002/151762, 2004/0039453, 2008/0057261,2008/0045782, 2010/0105979, 2011/0144417, and 2011/0201876 andInternational PCT Publication Nos. WO 2008/057261 and WO 2007/097994,can be employed with the present invention, with the above-identifieddisclosures being incorporated herein by reference in their entirety.The devices or structures described herein can be employed or introducedinto the pelvic region of the patient transvaginally, percutaneously orin any other manner known by those of ordinary skill in the art.

Referring generally to FIGS. 2-6, various embodiments are shown of thetissue constraining or positioning implant system 10 having one or moreattachment points in one or more membranes or other target tissuelocations. Embodiments can function to restrict, limit or controlmovement of the mid or distal urethra, or surrounding tissue. Further,embodiments can assist in resisting forward rotational movement of theurethra or surrounding tissue, and can provide support and tensionduring events, such as coughing or physical activity. Various advantagesof the implant 10 embodiments depicted herein include, frontal accessand simpler anatomy to address, less vascularity and bleeding, reducedrisk of creating retention and de novo urge, and the ability to test forcontinence before surgery. Additionally, the implants 10 act to opposerotational movement of the urethra, thereby eliminating or lessening theeffects of stress urinary incontinence.

A viable treatment, therefore, will be one that most efficiently opposesrotational movement of the urethra. Urethral rotation still occurs innon-hypermobile patients, just to a lesser extent. The concept ofrotational mechanics also suggests that obturator anchored implantsshould be placed with higher initial tension and be positioned as fardistally as possible on the urethra. Applying this principle ofrotational resistance gives rise to devices in accordance with thepresent invention whereby urethral movement is inhibited near the distalurethra, while the bladder neck continues to move.

When a midurethral support is implanted in the female patient, themidurethra is restrained from movement. However, the bladder neckremains mobile and moves downward during a stress event due to elevatedabdominal pressure. The resultant effect is that the urethra can bekinked at the midurethra location, causing a closure of the urethra.Like kinking a garden hose, the flow of fluid is restricted orprevented.

Referring again to FIGS. 2-8, the implant system 10 can include one ormore anchor devices 12 adapted for use with various embodiments of thepresent invention, including those adapted to penetrate tissue or softtissue as disclosed herein. Certain of the devices 12, e.g., the lateralanchor 16, can be generally provided in a back-to-back serialconfiguration, with a suture or like extension member extending toprovide adjustable support between the anchor devices 12. As shown inFIGS. 7-8, the anchor devices 12 can include one or more first medial orproximal anchor devices 14, and one or more second lateral or distalanchor devices 16.

Referring generally to FIGS. 9-23, the lateral anchor devices 16 caninclude a body portion 18, one or more expandable barbs 20, athru-aperture 22, and an opposing end 24. A suture 30 or like member isadapted to string or thread through the respective apertures 22 of aseries or array 16 n of such anchors to define the general elongate andexpandable configuration shown. The array of anchors 16 n can beinserted within and along the interior lumen 41 of a needle 40, cannulaor like inserter or delivery tool.

In various embodiments, the lateral anchor devices 16 can be directedfor engagement with tissue distal the anchors 14 at target sites such asthe obturator foramen, obturator internus muscle, sacrospinous ligament,prepubic fascia or muscle, abdominal fascia, rectus fascia,puboprostatic ligament, the tendinous arch of the levator ani, theCooper's ligament, and the pubic symphysis. Other distal target tissuesites for the anchors 16 capable of permitting tensioning support forthe perineal membrane or other urethra-supporting tissue is envisionedas well. Unlike conventional sling device and implantation methods, thepath from the perineal membrane to the distal anchor 16 of the presentinvention can follow a generally straight line into the obturatorinternus muscle, or like distal tissue. Furthermore, because itintersects the muscle at an oblique angle, more tissue can be engagedfor securement.

Referring generally to FIGS. 11-16, the needle 40 can include an exit oropening 42 at a needle tip 42 a. A series of anchors 16, such as theanchor array 16 n, can include a lead anchor 16 a adapted to first exitthrough the opening 42 upon deployment. In certain embodiments, thesuture 30 path is generally undulating while within the needle 40, andeven upon initial departure from the needle 40 (FIGS. 11 and 13-15),while it is generally brought into a straight or taut state upon fulldeployment from the needle 40 (FIGS. 7, 12 and 16). The end portion 24of the lead anchor 16 a can be permanently attached to the end of thesuture 30 via bonding, adhesive, welding, knotting, or the like. Theanchor 16 or its respective components can be molded together orotherwise attached to create the construct depicted and disclosed.

Each successive anchor 16, e.g., after lead anchor 16 a, is alternatelyarranged such that they can be closely aligned along or within the lumen41 of the delivery needle 40. The suture 30 passes through these anchors16, and the anchors 16 can be adapted to slide on the suture 30. Again,when the anchor array 16 n is inside the needle 40, the suture 30 canfollow a serpentine or otherwise undulating path. A pusher rod 43, orlike mechanism or device may be biased or pushed against the proximateanchor 16 b (e.g., opposite end from the lead anchor 16 a), asillustrated in FIGS. 14-15, such that the array of anchors 16 n pushesagainst the distal end, or lead anchor 16 a, that is fixed to the suture30. This can help maintain the close alignment of the anchors 16 whileinside the lumen 41 of the needle 40 and thus facilitate deployment.

When the delivery needle 40 is at the intended anchor position or targettissue, the array 16 n can be deployed in various ways. In one method,the pusher 43 simply forces the anchors 16 n out of the lumen of theneedle 40. Some suture 30 tension can be maintained so that the anchors16 n are efficiently driven out in a straight line or path. In anothermethod, the position of the anchors 16 n relative to the tissue remainsfixed or stationary (e.g., with the aid of the pusher 43) while theneedle 40 is retracted back or away (e.g., slid) from the array 16 nsuch that the anchors 16 are deployed from the lumen 41. With eitherapproach, after the array of anchors 16 n is completely outside theneedle 40, tension can be applied against or upon the suture 30. Thisforces the individual anchors 16 to slide together and tilt outward atan angle relative to the suture while they embed into the tissue,creating firm engagement. The tilt angle, relative to a straightenedsuture, ensures engagement into tissue and is preferably 25 to 45degrees. The pusher rod or member 43 can be a wire or tube that fitsinside and through the proximal end of the needle 40, through the lumen41, and acts against at least one of the anchors, directly orindirectly, including the most proximal anchor.

Other embodiments of the anchor 16, as shown in FIGS. 18-20, can includean extended thru-aperture 22, generally along the length of the body 18of the anchor 15, that allows the suture 30 to pass in a generallystraight line through the array 16 n while in the lumen 41 of the needle40, and bend or reform into a general serpentine or undulating shapeafter the anchors 16 have been deployed and the barbs 20 expand outwardfor tissue engagement. This approach can have the advantage of utilizingthe suture 30 tension to resist the rotation of the barbs 20 workingagainst tissue.

Referring generally to FIG. 21, and various embodiments, when the barbs20 are engaged within the target tissue site, they can be subjected to amoment load M. This moment is opposed by the suture line tension momentwhich is proportional to T*L, where T is the tension and L is the momentarm. This moment arm increases as the angle θ of the serpentine orundulation increases. Thus, such a configuration during initialapplication of tension is better able to work in the tissue than one inwhich the suture is in a straight line (θ=0) after anchor deployment. Bycontrolling the serpentine angle in the barb design, the effectivenessof the anchor array 16 n may be optimized. The bending stiffness of thesuture 30 will also affect the rotational resistance, and a solid suture30 will have more bend stiffness than a braided one of similar material.

Another embodiment of the anchors 16 and anchor array 16 n configurationis provided in FIGS. 22-23. A dual-tipped/barbed anchor 60 is includedthat flexes about a hinge 62 at the base 18. Again, the anchors 60 areprovided in an array 60 n with a lead anchor 60 a. The array of barbs 16n are spaced apart along the suture 30 while inside the lumen 41 of theneedle 40, and condense or compress together as they are pushed out ofthe needle 40, or the needle 40 is removed, and put under tension. Thetwo barbs 20 of each anchor 60 are forced further open by the bodyportion 18 of the adjacent abutting anchor 60. For instance, the bodyportion 18 of the preceding anchor 60 can slide into the gap between thetwo barbs 20 of the next leading anchor 60 to cause those barbs 20 toflare out or expand, as shown in FIG. 20. This configuration may be morecompact than the single barb designed anchor 16 and also may not dependas much on the suture 30 tension to oppose the load on the tips. Namely,the tissue fixation may better resist backing out of the tissue targetsite compared to various other embodiments for cases where an increaseddegree of fixation is required or desired.

In certain embodiments, the anchors 16, or anchors 60, can be fabricatedusing a metal injection molding process, or from a molded resin material(e.g., 720FC resin, polycarbonate, PEEK, nylon), with an exemplaryProlene monofilament, or braided, suture 30 threaded therethrough. Thecomponents can be easily inserted through the lumen 41 of the needle 40and arranged in an alternating pattern—e.g., angular orientationpattern—along the suture 30. For instance, the alternating angularpattern of the anchors 16 in FIG. 7 is approximately 180 degrees,whereas the alternating angular pattern of the anchors 60 in FIG. 22 isapproximately 90 degrees. Of course, a myriad of alternate angularpatterns and orientations are envisioned for embodiments of theinvention depending on the particular deployment, anchoring andengagement needs. The suture 30 can be lightly tensioned to bring allthe anchors 16 in the array 16 n together while holding the pusher 43 inplace. Again, while holding the pusher 43 stationary, the needle orcannula 40 can be retracted, leaving the array 16 n, or 60 n, and therespective anchor barbs 20 embedded in tissue. A slight tug of thesuture 30 can bring the anchors together and take up any initial slackin the suture line 30.

As shown in FIGS. 7-8, embodiments of the tissue anchoring devices andmethods can include a reduced trauma explantation (e.g., removal fromtissue) configuration and mechanism for the barbed soft tissue anchors,e.g., the anchors 16, described and depicted herein. For instance, onesolution is to attach an explantation tether 50 to the leading anchor 16a of the array 16 n. This could be in the form of a suture, orcontinuation of the existing traction suture 30 that leads back out ofthe implantation path. To remove the anchor 16, or anchor array 16 n,the physician simply pulls on this tether 50, causing the anchor 16 todouble-back on itself and pull out atraumatically—e.g., through thedefined tissue path or tissue penetration site. This could be doneduring the initial implantation procedure or at a later time in theevent that the device 16, or implant 10, must be disengaged or removed.

The average normal pullout force of an engaged anchor 16 or anchor array16 n can be approximately 4 to 7 lbs with various embodiments, while theexplantation force of the embodiments having the explantation tether 50can be around 1 to 3 lbs. By leaving a segment of loose tether 50attached to the leading anchor 16 a, the physician can pull out theentire assembly by tugging on it. Pulling up on the explant suture ortether 50 causes the anchors to double-back on themselves and continueout of the tissue in the non-resistant direction, lead by anchor 16 a.This reduces the removal force and associated tissue trauma. This typeof explant method can be used with any implanted device that has ananchoring end that is generally flexible or segmented enough (e.g.,series of separate anchors 16 strung along the member 30 of the anchorarray 16 n) to allow doubling-back. The implant can be designed suchthat the free end of the explant tether 50, generally opposite the endattached to or proximate the lead anchor 16 a, can be accessed by aphysician. This could be done by leaving the suture 50 end hanging outof the implantation puncture. The free end can be later trimmed orremoved when explantation is no longer needed. In various embodiments,the tether 50 can be constructed of an absorbable material.Alternatively, a tag or loop can be included at the free end of thetether 50. This tag or loop can remain just below the skin surface andcan be accessed later if the implant 10 or device 16 requireexplantation.

The anchor array 16 n is thread or otherwise provided along the suture30, or paired sutures 30 (e.g., FIG. 17), and can be delivered via apercutaneous passage inside a hypotube or the needle 40. This allows forcontrolled delivery of the anchor array 16 n such that the needle tip 42a can be selectively repositioned before the anchors are set in softtissue.

Referring generally to FIGS. 13-16, embodiments of the needle system 40can include a slotted needle configuration, with the needle 40 includinga slot or groove 64 along a distal or end portion of the needle 40 bodysuch that a portion of the suture 30 can pass outside the lumen 41 ofthe needle 40 during deployment. The slot 64 can be created in or alonga portion of the needle 40 by milling, laser cutting, EDM machining, orusing other similar fabrication, manufacturing or formation methods. Forneedles 40 requiring some curvature to facilitate use and deployment,the slot machining may be done before or after the bending operation forthe needle 40. With a curved needle 40, the slot 64 can be on the outerside of the bend. This, in turn, can promote keeping the portion of thesuture 30 that lies in the slot 64 to stay inside the lumen 41 whenunder tension.

As described, a pair of sutures 30, e.g., FIG. 17, can pass through eachanchor 16 in the array 16 n, and follow a serpentine or undulating pathwithin the needle 40. A knot, bead, stop, member or like structure 31 atthe distal end of the suture 30 proximate or in front of the leadinganchor 16 a can act as a stop for the lead anchor 16 a. A second knot,bead, stop, member or like structure 31 a, can be included at a portionof the suture 30, or paired suture, near the most proximal anchor 16 b,and/or outside the slot 64 (e.g., FIGS. 13-14).

Embodiments employing a paired suture 30 configuration can includemembers, structures or other constructs, including the apertures 22 ofthe anchors 16, having a generally rectangular or oval shape such thatthe pair can be passed through to hold them side-by-side. By doing this,the barbs 20 are less able to rotate on the axis of the suture line 30and will stay properly oriented. By creating anchors 16 that havedifferent through hole angles or shapes it is also possible to fix theangular position of the anchors 16 n to create a larger anchor spread.

Again, a pusher 43 can be positioned behind, or abut against, theproximal anchor 16 b that acts as a stop (prevent backing out of array16 n within needle lumen 41) during the needle insertion and deploymentprocess. The pusher 43 can also serve to maintain the anchors 16 andrespective barbs 20 barbs in a fixed position, relative to the tissue,as the needle 40 is retracted or pulled away from the array 16 n. Theslot 64 can be sized to allow the suture 30 to freely pass through, butdoes not allow the anchors 16 or respective barbs 20 out through thatportion of the needle 40. The length of the slot 64 can assume many sizeconfigurations, depending on the size of the anchors 16 in the array 16n and the number of serially aligned anchors 16 in the array 16 n.However, the slot 64 could also extend along the entire length of theentire needle 40 in certain embodiments, or take on various other sizeand shape configurations depending on particular device and applicationneeds. Moreover, the slot 64 length can be defined by the anticipatedlength of depth of the tissue targeted for penetration.

Further, embodiments of the needle 40 including the slot 64configuration can facilitate easier and more efficient use of a medialanchor 14. The medial anchor 14 is attached to, or threaded or providedalong a portion of the suture 30 that does not need to be constrained orfit within the relatively thin and small needle 40 or lumen 41. As such,the slot 64 provides a length of suture 30 that can ride outside of thelumen 41, with the medial anchor 14 attached or provided along thatexternal length of suture 30. This provides greater flexibility for thedesign and construct of the medial anchor 12 and the respective deliverymethod. In addition, the pusher 43 will not interfere (e.g., traversealongside) with the proximal length of the suture 30 provided before theanchor array 16, as the proximal portion of the needle lumen 41 will befree of the suture 30. Also, there can be a reduced tendency for theanchors 16 to wedge together and jam if subjected to excessive pushforces because the slot 64 provides more room for movement and spreadingcompared to non-slotted embodiments of the needle 40 where everythingwithin the lumen 41 is confined to the lumen walls. Still further, theslot 64 keeps the exiting suture 30 portion from unwanted turning andtwisting, thereby assisting in keeping the attached anchors 16 alsofixed in a preferred angular orientation within the needle 40.

The proximal stop 31 a can also be used to keep the anchor barbs 20 fromspreading apart during assembly and during the deployment of the anchors16 n. With the slotted needle 40, the knot, bead or stop 31 a can bepositioned either inside or outside the lumen 41. One advantage forpositioning the stop 31 a outside is that it can introduce enough dragto enable retraction of the needle 40 while still keeping the anchors 16in place. In certain embodiments, this can preclude the need for aninternal pusher 43 to hold the anchors 16 in place upon deployment. Thestop 31 a could take on nearly any size or shape, and material. Also,the anchor system can include intermediate knots, beads or stops 31 thatseparate smaller or distinct groupings of anchors 16. For example, astop 31 between a fourth and fifth anchor 16 can result in two groups offour barbs forming on the suture line 30. Such a grouping configurationcan assist in redistributing the tension on the suture line 30 in stagesor segments, as well as to reduce the amount of pulling that is requiredto initially set the anchors 16 in tissue. It can also improve theoverall tissue anchoring force and stability.

Embodiments of the lateral anchors 16 can include self-expandingstructures or materials such that the anchors 16, or anchor array 16 n,can be generally collapsed or reduced in sized during deployment, withor without a needle device 40, and expanded after penetration in thetarget tissue site to provide desired tissue engagement. Certain anchors16 can include one or more shape memory portions, or living hinges, tofacilitate this structural self-expansion upon deployment and tissueengagement. Further, embodiments of the lateral anchor 16, or anchorarray 16 n, can include helical portions, threaded portions, hooks,clips, flexible barbs, textured surfaces, and like members or structuresto promote tissue engagement. In addition, still other embodiments ofthe lateral anchor 16 can be adapted to include a plurality of anchors,extending from one or more separate members 30, spread out into multipleanchoring features for deployment into tissue to provide support andtreatment. Such a spanning multi-anchor device 16 can create aneo-ligament to reduce or eliminate rotation of the urethra U orsurrounding tissue through the use of multiple anchoring spots.

As shown in FIGS. 24-27, the medial anchors 14 can include metal or likemembers or tubing, such as nitinol, stainless steel, titanium, orpolymer, laser cut or formed into longitudinal petals 44 that arecapable of selectively collapsing and expanding in a flex leafconstruct. The cutting may be done such that any number of petals isformed. Exemplary embodiments can include two, three or four petalconstructs.

In certain embodiments, the formation and configuration of the petals 44can be accomplished using a heat-treatment process where the petals 44are set in the opened state, and whereby the ends of the petals 45 adistance from the hinges 48 are radially expanded and set in thatposition. However, due to the elasticity or hingability of the material,these petals 44 can be temporarily closed, facilitating the insertion ofthe anchor 14 into a small puncture, such as within the tissue of theperineal membrane PM. Once positioned, the anchor 14 can self-expand,e.g., via shape memory, to the opened state to provide tissue engagementand fixation.

Various embodiments of the medial anchors 14 can include slots 49 (e.g.,laser cut) in the petals 44 to develop the bend or living hinges, asshown in FIGS. 26-27. These slots 49 can be very narrow (e.g.,approximately 0.001″-0.003″ wide) and allow a limited degree oflocalized bending along a portion of the corresponding petal 44. As aresult, the petals 44 can easily flex to the opened state, but canrequire a greater load to move beyond that point where the slots 49 haveclosed together. Thus, the petal 44 is less likely to overbend or flipout of position. Another advantage is that this embodiment can be easilyadapted to a variety of flexibility configurations depending on thedesired attributes. For example the number, sizing, and spacing of theslots 49 can be varied to adjust the amount of allowable bending and theload required to achieve that bend. As with the previously describedembodiments, the component or petal 44 can be heat-set to the openedposition so that it self-expands from a closed position.

Embodiments of the medial anchor 14 can include a body portion 47 andone or more apertures therethrough to receive or connect with the suture30. Further, a medial needle device or oversleeve 59 can be includedwith embodiments of the invention to facilitate introduction anddeployment of the medial anchor 14. FIGS. 24-25 show the anchor 14 in acontracted state within the lumen of the needle 59 during deployment,with FIGS. 26-27 showing the anchor 14 expanding when pushed, pulled orotherwise removed from the inner constraints of the needle 59. Exemplaryanchors 14 can include substances, such as an adhesive (e.g., lightactivated adhesive) to assist in the tissue engagement process.

FIGS. 28-30 depicts a medial anchor 14 at the perineal membrane PMimplanted via a transverse insertion through the anterior vaginal wall,between the perineal membrane PM and the superficial skin lateral to theurethral meatus, according to an embodiment of the implant 10. While theanchor 14 is held in this position, a needle 40 pass is made from thelateral side of the meatus that intercepts the medial anchor 14 andpasses through a pre-made hole or punctures the anchor 14. The needle 40pass continues on to the obturator muscle, or other distal tissue, wherethe lateral anchor 16, or anchor array 16 n, is delivered. The medialanchor 14 can be placed in the superficial space between the perinealmembrane PM and the distal skin layer at the meatus. The small medialanchor 14 can be held with a custom holder or forceps until theintersecting needle 40 pass.

Referring generally to FIGS. 29-30, while the anchor 14 is held, theneedle 40 passes through the hole in the anchor 14 and after the distalanchor 16 is deployed and the needle 40 has been retracted, there willbe a trailing suture 30 that can include a one-way slider 90, or likesliding or locking device, on it. The slider 90 can be pushed along thesuture 30, mating with the anchor 14. Tension is increased by pushingthe slider 90 farther along the suture, thereby pressing tighter againstthe anchor 14, and/or the surrounding tissue. An advantage to thisapproach is that the placement of the medial anchor 14 at the perinealmembrane can be greatly controlled, and can be deployed with minimaldisruption to the surrounding tissue. In contrast, an anchor 14 that ispassed through a skin puncture lateral to the meatus may need to beturned such that its major axis is parallel to the puncture hole, thenrotated or expanded to face the perineal membrane. The medial anchor 10for this transvaginal method generally would not have the same size ororientation limits and could therefore be substantially larger andbetter able to resist pull-through failure.

Furthermore, the medial anchor 14 position could in fact be in theanterior wall of the vagina V for any of the disclosed treatment andanchoring embodiments. Unlike the previous attempts that focused on theanterior vagina, the traction force vector will be more parallel to thevaginal wall with the disclosed embodiments of the present invention sothat an optimal rotational resistance of the urethra U can be achieved.

The anchor 14 can be implanted via a puncture at the skin surface, butthe introducer needle 40 can still be passed within the thickness of thevaginal wall as described. The anchor 14 can be constructed of aflexible material to reduce the sensation or recognition of the anchor14 to the patient or the patient's sexual partner. Furthermore, whilethe anchor 14 is under tension it can bend such that the line of forceis generally more parallel to the suture (e.g., reducing the“cheese-cutter” effect). Alternatively, the two ends of the medialanchor 14 can be relatively rigid but flexible in a middle body portion,such that the urethral kinking effect is enhanced when there is tension(e.g., if the flex is near the perineal membrane).

The support or extension members 30 can apply mechanical traction to theurethra in a manner similar to a mini-sling device. However, a benefitof embodiments of the present invention is that the transvaginalplacement of the structures and devices does not leave exposed material(e.g., implant mesh) inside the vaginal cavity. For example, theimplanted device 10 position is generally blind and lies beyond thesuperficial mucosal layer of the vaginal wall. Reducing or eliminatingthe exposed material minimizes the risk of infection, irritation at thesurface of the vaginal wall, and provides cosmetic improvement andreduces interference with sexual activity.

As shown in FIGS. 31-38, various embodiments of the implant system 10can include anchoring elements or portion is fixed on each side of theurethra, on the far side of a tissue layer that is known to haverelatively high strength and toughness. The medial or proximal anchor 14can include a “toggle” anchor, which is a small, elongated structurethat can be placed through a small puncture or like incision and thenrotates after deployment so that it cannot back out through the incisionhole. Other anchoring devices and methods can be employed with thepresent invention as well.

As shown with various embodiments, the suture 30 can weave or thread inand out of, and along, the tissue, e.g., the perineal membrane, toprovide a supportive undulating layout for the suture 30 and implant 14combination. This can facilitate attachment, better distribute pullingforce on or along the tissue, and provide like support benefits. Forinstance, one or more sutures 30 can be woven or interwoven (e.g., inand out) of the perineal membrane, with anchors 14 engaging at orproximate the posterior symphysis. When tightened, the suture 30 pullsand compresses tissue toward the posterior symphysis to provide supportand strength. Again, a suture lock device or technique can be includedto fix the tension or support adjustment of the sutures 30.

Placing the anchor device 14 on the far side of the fascia isadvantageous because it is less likely to be palpable than one placed inthe mucosal and muscle layer—also because it is placed in an area ofloose connective tissue in which the toggle anchor 14 can easily rotateinto a locking orientation.

The distal or anchor device 16 is placed in a lateral or superiorposition such that a connection (e.g., suture 30 or wire connection)between the medial and lateral anchors 14, 16 can provide tensilesupport for the urethra during stress events. The anchor device 16 canbe fixated to, or engaged with, the obturator membrane, obturatorinternus, tendinous arch of the levator ani (white line), the Cooper'sligament, sacrospinous ligament, prepubic fascia or muscle, the pubicsymphysis cartilage, abdominal fascia, or other stable anatomicalfeatures.

The final position of the implanted device 10 creates a supportstructure that is similar to a needle suspension. The medial anchor 14can spread or better distribute the tension load over a larger surface(as opposed to a thin suture cutting edge surface) than other proceduresand devices. This, in turn, promotes stability of the anchor andconnecting suture or spanning support member.

Various procedural steps or methods can be employed to deploy theimplant 10 of the present invention. In one embodiment, as demonstratedwith FIGS. 31-35, the medial toggle anchor 14 is implanted, a needle 70is withdrawn, a free suture or connector end is delivered through theinsertion opening, the lateral (e.g., obturator) anchor 16 is deliveredand implanted, and the connecting suture 30 is properly tensionedbetween the anchors 14, 16 to provide proper support.

The needle 70 can be adapted to contain the toggle anchor 14 with a tip70 a directed for penetration through the perineal membrane or likeparaurethral support tissue. In other embodiments, the toggle anchor 14can include a sharp or beveled tip to facilitate penetrating through thetarget tissue. The needle 70 is then withdrawn with the suture 30extending therefrom and a distal anchor 16 attached or provided at theopposing free end of the suture 30. The anchor 16 can be small enough topass through the small punctures in the tissue and deploy at theobturator foramen or like tissue targets. Various delivery tools anddevices disclosed herein, or known, can be used to direct and deploy theanchor 16. Upon implantation of the anchor 16, the suture 30 can betensioned to provide the desired level of support for the paraurethraltissue (FIG. 35). In addition, the medial anchor 14 can include aone-way tension holding feature (e.g., zip tie-like) that allows thephysician to pull out excess suture material without the excess slippingback through the anchor 14.

FIGS. 36-38 show another embodiment of the implant 10 having a toggleanchor configuration. A suture needle 72 can be utilized to create aloop or “bite” 71 through the paraurethral tissue to provide additionalstability and anchoring support. The suture needle 72 can be includedwith the suture 30, and can be removable with certain embodiments.

In various embodiments, the suture 30 can be woven in and out ofmultiple portions of the perineal membrane or like tissue, with orwithout a medial anchor 14, such that pulling on the suture 30 cancompress or cinch up the tissue. One or more suture locking devices 77,e.g., diametric suture lock of FIG. 68, can be inserted through aportion (e.g., free end) of the suture 30 to selectively lock the suturein place after the desired tension is obtained. In certain embodiments,the suture locking devices 77 can include a one-way locking mechanismconstructed of a generally cylindrical body having one or more cuts 77 a(e.g., laser cut) defined in a surface or portion of the device 77 todefine inward extending tines 77 b. The tines 77 b can permit the suture30 to ride or slide within the device 77 in a direction not against thedirection of the tine 77 b angles. However, backing out of the suture 30will be prevented in the opposite direction when the tines 77 b grabonto the suture (e.g., braided suture) and restrict movement in thatdirection. Other suture locking devices are envisioned for use withvarious embodiment of the present invention as well.

As illustrated in FIG. 39, embodiments of the present invention caninclude a coil spring device 76 operably connected to one or more of theanchors 14, 16. The device 76 can be held in a slightly extended statethat generates a preload tension. The device 76 can include a springmechanism 78, which is connected at either end to the suture 30 and isforced open with stops 80 that impose a fixed extension against a rigidstructure or housing 82. Thus the spring 78 may extend, but only afterthe suture tension exceeds the preload force. Alternatively, aconventional coil extension spring can be employed such that when thespring relaxes to its solid height, some pretensioning load ismaintained—e.g., it is unable to further contract due to the coils beingin full contact. Other methods for mechanically creating initial tensionand load control are envisioned as well.

In certain circumstances, it may be desirous to provide pre-loadedtension options for one or more of the anchors 14, 16. Preloading can beachieved by pretensioning the suture during the implantation procedureor could be achieved by creating mechanical pretension internally in theanchor devices 14, 16, or mechanisms operably connected to the devices14, 16. As such, a constant rest load against tissue (which mightstretch) can be provided.

As shown in FIG. 40, embodiments of can include one or more generallyC-shaped, or like shaped, medial anchors 14. The anchors 14 can beplaced adjacent the urethra U to provide a medial anchor configuration.The sutures 30 can extend from the anchors 14 to one or more distalanchors 16.

Certain embodiments of the anchors 14, or 16, can includespace-expanding characteristics or attributes. A expandable portionanchors 14, 16 can be constructed of shape memory materials (e.g.,polymers or metals) adapted to collapse under a bias within a deliverytool or under other pressure, with the anchors 14, 16 expandable upondeployment to provide traction-like fixation or connectivity to tissue.

FIGS. 41-42 show an embodiment of the medial anchor device 14 having ananchor base portion 14 a and a dilating anchor portion 14 b. Thedilating anchor portion 14 b is adapted for deployment to rest orotherwise stop or abut against a portion of the perineal membrane PM, orother like tissue. The suture or other extension member 30 can extendbetween the two anchors 14, 16. In a rest state (FIG. 41), the dilatinganchor portion 14 b is not generally applying pressure to the urethra U.However, during a straining event or state, the dilating anchor portion14 b expands (e.g., expands under compression) to apply a level ofpressure on the urethra U to promote continence, as depicted in FIG. 42.

FIGS. 43-45 are directed to a medial anchor device adapted to puncturethrough the skin and into the perineal membrane PM or like tissue. Sucha superficial skin puncture can be targeted at the crease between thelabia minora and majus, directed at the space between the bulb ofvestibule and clitoral crus, in certain embodiments. A tube or deliveryneedle 84 can include or contain a pair of anchoring or stop members 86a, 86 b and at least a portion of the member 30. The needle 84 operablyconnects or carries the stop members 86 a, 86 b and extends beyond them.Upon insertion into the perineal membrane, as shown in 44, the deliveryneedle 84 can be removed, leaving behind the stop members 86 a, 86 b andthe member 30, such as a suture, with a stop member on each side of theperineal membrane PM. The members 86 a, 86 b can then be drawn tocompress or otherwise secure the stop members on each side of themembrane, as shown in FIG. 45. A knot or other device 87 or techniquecan be created or provided along a portion of the member 30, e.g., oneach side of the stop members 86 a, 86 b, to secure the members inplace. As an alternative to a knot, a clip, tie, washer, lock mechanismor other devices and techniques can be employed to secure the stopmembers 86 a, 86 b in place against the perineal membrane. Onceimplanted and adjusted, the device can provide tension and a twistingmotion on the membrane, thereby translating to rotational torque. Again,the free end of the extension member 30 can include one or more lateralanchor devices 16 as disclosed herein.

FIGS. 46-47 show a medial anchor device 14 having a generallystar-shaped construct. The device 14 is collapsible and expandable tofacilitate introduction and deployment. The anchor 14 can be constructedof a shape memory material such that it can be implanted in a collapsedstate (FIG. 47) and expands once through the tissue to provide desiredengagement (FIG. 46). Various metal or polymer materials can be used toconstruct such an anchor 14 to adjust tensioning and tissue positioningat the perineal membrane to promote continence. Other selectiveexpansion anchor devices can be employed as well, including anchorsconstructed of an expandable balloon or bladder-like material, adaptedto expand within a tissue or compartment. Other anchors can includethreading or drill-like configurations for engaging and anchoring intotissue such as the perineal membrane PM. Twisting or rotating motion ofthe anchor at the target tissue site (e.g., electric, mechanical ormanual), can facilitate penetration and affixation of the anchors withthe perineal membrane PM.

Certain embodiments of the medial anchor 14 can include structuresadapted to attach to or span across a portion of the perineal membrane,or like tissue, to facilitate engagement, compression or anchoring withthe tissue. For instance, a plate, mesh material, tissue cinchingdevice, stent-like device, ring, clip, coil, spring, strap, pad,patches, or similar structures, can be affixed to, directly orindirectly, the perineal membrane, with such anchors 14 then beingconnected to the lateral anchor 16 via the extension member 30. Thesestructures can be attached to tissue via sutures, anchors, and similartissue engagement devices. The anchors 14 and related structures caninclude rigid, semi-rigid or flexible polymer or metal materials.

One-way locking devices can be incorporated with any of the anchors 14,16, or along (e.g., thread along) the member 30 such that the physiciancan adjust the tensioning of the implant 10 to the desired level and fixthe tension for optimal support and the promotion of continence.

In use, a patient could be placed in a lithotomy position for theimplantation procedure. A physician may make one or more incisionsthrough the perineal tissue lateral to the urethra of the patient.Alternatively, the physician may make one or more vaginal incisions toaccess the tissue superior to the urethra. The physician may use theneedle delivery device 40 to implant the devices or anchors. The medialor proximal anchor 14 can then be implanted through the perinealincision, thereby reducing the invasiveness of the procedure. Thedelivery device 40 may be configured to allow insertion through a singleor multiple perineal or transvaginal incisions. In other embodiments ofthe implant treatment procedure, needle 40 can be directed “outside-in,”from the skin through the obturator membrane, then with an anchor 14engaged with the perineal membrane. Further, the anchor 14 can includesuture loops. The loops can be tied from the peritoneum side. From theobturator side, the multiple loops or sutures 30 can then be tied aroundthe anchor for fixation.

In other embodiments, the distal anchor 16 is a wrap-around deviceadapted to go around the inferior ramus. This, in turn, can reduce oreliminate the chance of pull-out from soft tissue. Sutures, clips,clamps, loops and like devices can be employed to facilitate and affixthe wrap-around configuration. Certain embodiments can use distalanchors, such as anchors 16, to attach to the retropubic space of thepatient as well, with the attached suture 30 again extending to themedial anchor 14 at the perineal membrane.

The implant 10, or corresponding anchors, can benefit from a woundhealing response that restores or even improves tissue strength.However, such healing and tissue reinforcement can take several weeks.As such, one solution to this problem is to implant the anchor 14 orgraft several weeks prior to implantation of the tensioning sutures andanchors 16, 16 n. The anchor 14 can be embedded or engaged at theperineal membrane with a minor procedure and allowed to fully heal andintegrate with the surrounding tissue for a period of days or weeks.Because there is no active loading on the anchor 14 during this period,the patient can maintain full physical activity levels during thishealing process. Then, in a follow-up visit, a minimal procedure isconducted to attach this fully anchored element 14 to the distal anchor16, or array 16 n, via the tensioning suture 30.

In certain embodiments, it may be beneficial to modify the target anchorzone or site (e.g., perineal membrane) through the use of injectablessuch as a scarring agent, proteins, polymers, or other materials thatsignificantly increase tissue strength in the region. After allowingthis treatment to set up, the continence implant 10 can be implanted ina follow-up procedure.

Alternatively, the full implant 10 can be implanted but left in aloosened state with the free end of the suture 30 left hanging or free.After several weeks, the implant 10 can be tightened by pulling thesuture 30 (or by adjusting a locking or securement device) further outand then trimming it off.

Below the perineal membrane is the superficial perineal pouch (SPP),which is large enough to accommodate various implants or anchors 14 forembodiments of the present invention. The SPP is the compartment of theperineum that lies between the perineal membrane and the perineal fascia(Colles fascia). The anterior SPP can be dissected from the frontal sidein order to expose the tissue in this space. This area generallyconsists of layers of connective tissue and fascia, and some thinmuscle. The tissue in this region is easily penetrated or compressedwith a blunt needle, until reaching the perineal membrane. Thus, therecan be ample room and favorable tissue properties in this region toaccommodate the implant 10 or anchoring devices.

FIGS. 48-54 depict implants 10 adapted for fixation with the perinealmembrane to provide adjustment (such as lift), to thereby providesupport and adjustment of the patient's urethra U. FIGS. 50-51 show anembodiment having two perineal membrane PM piercing or penetrationpoints, with the implant including a small cinch ring 100 adapted topull on the members 30 (such as suture, strand, mesh, etc.) to providethe desired adjustment—e.g., along a suture loop. Lateral anchors 16 canbe adapted to penetrate through the perineal membrane PM for fixationand securement distal the paraurethral tissue. The cinch ring 100 canslide up to the desired position along the members 30 to provideselective adjustment and tensioning, as shown in 51. The ring 100 caninclude a stop button or collar having a one-way draw string or deviceto provide securement as well. FIGS. 52-53 show an embodiment of theimplant adapted for a single perineal membrane piercing or penetration.Further, FIG. 54 depicts a curved profile for the ring 100 to distributepressure from the implant 10.

As shown in FIG. 55, embodiments of the implant system 10 can includemembers, such as sutures 30, adapted to cross over each other, withdistal end anchors 16 fixated in tissue away from the perineal membranePM. This, in turn, can coapt or compress the urethra while providingtension and desirable support characteristics, while reducingundesirable rotation. Medial anchors 14, such as patches or like anchorstructures, can press against, affix or engage the perineal membrane toprovide a larger anchoring area.

Certain embodiments, like that shown in FIG. 56, can engage and anchorto the perineal membrane with only sutures 30. Namely, a length ofsuture 30 is pushed through the tissue (e.g., one on each side of theurethra U in the perineal membrane PM) with an end anchored in thedisclosed distal anchor target tissue via anchor 16 (e.g., obturator orlike target locations) and another end anchor 102 anchored in othertissue, such as the rectus fascia or like tissue.

FIGS. 57-62 are directed various embodiments of anchor introductionsystem 110 for use with embodiments disclosed herein. FIGS. 57-58 showproblems with tissue deflection that can occur when the needle 40punctures the skin, for those embodiments employing percutaneous anchoror implant deployment, as the needle 40 approaches the perineal membranePM, next to the urethra U. The needle 40 can be undesirably divertedlaterally before puncturing the perineal membrane PM. Embodiments of thesystem 110 are therefore provided to limit the movement of tissue beingpunctured or traversed by a needle deployment device 40 to ensure that aproper and desirable puncture depth is achieved.

The system 110 can include the needle 112 having a helical orcorkscrew-like end member 114. Upon insertion of the member 114 throughthe skin and toward the perineal membrane PM, the needle path iscontrolled such that it does not divert laterally. The coil member 114will engage the perineal membrane PM (FIG. 61) and provide an operativepath for the needle device 40 to enter through the skin and through themembrane PM (FIG. 62). In certain embodiments, the member 114 can beconstructed of a bioabsorbable material, such as a bioabsorbablepolymer, and left behind in the patient. As such, the member 114 canserve as a temporary support for an anchor device 14 inserted via theneedle.

As shown in FIGS. 63-67, a tissue separation device 120 can beconstructed as a rigid or elastic part that includes a vacuum chamber122 into which tissue can be drawn, one or more vacuum ports 124connected to an external vacuum source, and an aperture 126 throughwhich an introduction or delivery device 40 can pass.

The device 120 can be particularly useful in creating appropriate needlepathways for minimally invasive (percutaneous) insertion of implants oranchors. The traction provided by the vacuum also serves to hold thetissue stationary so that minimal “tenting” or displacement of thetissue occurs during the needle penetration.

The tissue separation device 120 includes features specifically directedto creating separation of tissue layers. The aperture 126 can besurrounded by a perimeter configuration that is angled down and adaptedto contact tissue to form an interior vacuum seal. The perimeter can beconstructed of a rigid or elastic material that is suitable for forminga good seal against tissue, such as the perineal membrane or the vaginalmucosal layer.

As shown in FIG. 64, the interior geometry of the device 120 is sizedand shaped such that only the thin tissue layer is drawn into the cupspace. The tissue wall is drawn in because it is more elastic and isthin enough to fold into the space. For vaginal wall traction, theunderlying muscularis is too thick and stiff to fit into the space. Assuch, a separation of the tissue layers is created.

A first anchor (e.g., toggle) 14 of an implant device 10, as shown inFIGS. 65-66, can be introduced through the aperture 126 that penetratesthrough the mucosal or other tissue layers, leaving the anchor 14deployed on the opposite side of the tissue. After the first anchor 14of the implant is deposited or fixated, the needle 40 can be partiallywithdrawn into the dissected space and redirected toward the distal orlateral anchor target (e.g., via anchor 16, or anchor array 16 n).

For those embodiments including one or more needles 40 to introduce anddeploy anchors for tissue engagement, a trocar slidably housed withinthe needle to control and facilitate tissue traversal and piercing orpenetration at the target site.

The systems, devices, configurations and methods disclosed herein havegenerally described anchors that are symmetrically, bilaterally,positioned about the urethra. However, a single side deploymentconfiguration can still achieve continence and is available with variousembodiments. For instance, a single medial anchor 14 and lateral anchor16, or lateral anchor array 16 n, can be connected by a suture 30 tosupport and adjust the perineal membrane, above, below, or on a side ofthe urethra.

The systems, their various components, structures, features, materialsand methods of the present invention may have a number of suitableconfigurations as shown above. Various methods and tools forintroducing, deploying, anchoring and manipulating implants or to treatincontinence and prolapse as disclosed in the previously-incorporatedreferences are envisioned for use with the present invention as well.

A variety of materials may be used to form portions or components of theimplants and devices, including Nitinol, polymers, elastomers, porousmesh, thermoplastic elastomers, metals, ceramics, springs, wires,plastic tubing, and the like. The systems, components and methods mayhave a number of suitable configurations known to one of ordinary skillin the art after reviewing the disclosure provided herein.

All patents, patent applications, and publications cited herein arehereby incorporated by reference in their entirety as if individuallyincorporated, and include those references incorporated within theidentified patents, patent applications and publications.

Obviously, numerous modifications and variations of the presentinvention are possible in light of the teachings herein. It is thereforeto be understood that within the scope of the appended claims, theinvention may be practiced other than as specifically described herein.

The invention claimed is:
 1. A system for treating incontinence in apatient, comprising: a first implant device having at least one non-meshfirst medial anchor, a first distal anchor, and a first extension memberoperably connecting the at least one first medial anchor and the firstdistal anchor, the first medial anchor having an extendable transverseextension portion adapted to engage a portion of the perineal membraneto provide support for the urethra to restore continence; and a secondimplant device separate and not physically connected, directly orindirectly, with the first implant device and having at least onenon-mesh second medial anchor, a second distal anchor, and a secondextension member operably connecting the second medial anchor and thesecond distal anchor, the second medial anchor having an extendabletransverse extension portion adapted to engage a portion of the perinealmembrane, separate from the portion of the perineal membrane, and at anopposing side of the urethra, engaged by the at least one first medialanchor, to assist in supporting the urethra to restore continence, andwherein the separated first and second implant devices together form ageneral V-shaped support configuration relative to the perinealmembrane.
 2. The system of claim 1, wherein the first extension memberincludes a suture.
 3. The system of claim 1, wherein the first extensionmember is selected from a group consisting of: a braided member, anelongated mesh, a flexible rod, a rigid rod and a length-adjustablemember.
 4. The system of claim 1, wherein the first distal anchorincludes a first array of anchors, each of the first array of anchorshaving expandable barbs and being operably connected to the firstextension member.
 5. The system of claim 4, further including anintroduction needle having a lumen extending therethrough, wherein atleast the first array of anchors are adapted to traverse the lumen in acompressed state.
 6. The system of claim 1, wherein the second distalanchor includes a second array of anchors, each of the second array ofanchors having expandable barbs and being operably connected to thesecond extension member.
 7. The system of claim 1, wherein the at leastone first medial anchor includes one or more expandable fins adapted forengagement with the portion of the perineal membrane.
 8. The system ofclaim 1, wherein at least the second medial anchor includes expandablefins adapted to engage the second medial anchor device to the portion ofthe perineal membrane separate from the portion of the perineal membraneengaged by the at least one first medial anchor.
 9. The system of claim1, wherein the portion of the perineal membrane engaged by the at leastone first medial anchor is on a side of the urethra.
 10. The system ofclaim 1, wherein the portion of the perineal membrane engaged by the atleast one first medial anchor is generally above the urethra.
 11. Thesystem of claim 1, wherein the portion of the perineal membrane engagedby the at least one first medial anchor is generally below the urethra.12. The system of claim 1, wherein the first distal anchor is adapted toengage a target tissue site selected from the group consisting of: theobturator foramen, obturator internus, abdominal fascia, sacrospinousligament, prepubic fascia, rectus fascia, the tendinous arch of thelevator ani, the Cooper's ligament, and the pubic symphysis cartilage.13. The system of claim 1, wherein the at least one first medial anchoror the first distal anchor include an adhesive to assist in tissueengagement.
 14. The system of claim 13, wherein the adhesive is alight-activated adhesive.
 15. A system for treating incontinence in apatient, comprising: a first implant device having a non-mesh firstmedial anchor and a first extension member, the first medial anchorhaving a pivotable radial extension portion adapted to affix to aportion of the perineal membrane of the patient on a first side of theurethra; a second implant device separate and unconnected from, directlyor indirectly, the first implant device and having a non-mesh secondmedial anchor and a second extension member, the second medial anchorhaving a pivotable radial extension portion adapted to affix to aportion of the perineal membrane of the patient on a second side of theurethra opposite the first side of the urethra, such that the separatedfirst and second implant devices together form a general V-shapedsupport configuration relative to the perineal membrane; and whereintensioning adjustment on at least the first implant device providessupport for the urethra to restore continence.
 16. The system of claim15, wherein tensioning adjustment on the first implant device and thesecond implant device provides support for the urethra to restorecontinence.
 17. The system of claim 15, wherein at least one of thefirst extension member and the second extension member includes asuture.
 18. The system of claim 15, wherein at least one of the firstextension member and the second extension member includes an elongatemesh.
 19. The system of claim 15, further including a first distalanchor device operably connected to the first medial anchor via thefirst extension member.
 20. The system of claim 19, wherein the firstdistal anchor device includes a first array of anchors, each of thefirst array of anchors having expandable barbs and being operablyconnected to the first extension member.
 21. The system of claim 20,further including an introduction needle having a lumen extendingtherethrough, wherein at least the first array of anchors are adapted totraverse the lumen in a compressed state.
 22. The system of claim 19,wherein the first distal anchor is adapted to engage a target tissuesite selected from the group consisting of: the obturator foramen,abdominal fascia, rectus fascia, the tendinous arch of the levator ani,the Cooper's ligament, and the pubic symphysis cartilage.
 23. The systemof claim 15, further including a second distal anchor device operablyconnected to the second medial anchor via the second extension member.24. The system of claim 23, wherein the second distal anchor deviceincludes a second array of anchors, each of the second array of anchorshaving expandable barbs and being operably connected to the secondextension member.
 25. The system of claim 15, wherein at least the firstmedial anchor device includes expandable fins adapted to affix the firstmedial anchor device to the portion of the perineal membrane.
 26. Thesystem of claim 15, further including an introduction needle having alumen extending therethrough.
 27. A system for treating incontinence ina patient, comprising: a first implant device having a non-mesh firstmedial anchor device, a first distal anchor device, and a firstextension member operably extending between the first medial anchordevice and the first distal anchor device, the first medial anchordevice having one or more member portions extendable out radiallytherefrom and adapted to affix to a portion of the perineal membrane ofthe patient on a first side of the urethra and the distal anchor deviceadapted to affix to tissue away from the perineal membrane; a secondimplant device physically separate and unconnected, directly orindirectly, with the first implant device and having a non-mesh secondmedial anchor device, a second distal anchor device, and a secondextension member operably extending between the second medial anchordevice and the second distal anchor device, the second medial anchordevice having one or more member portions extendable out radiallytherefrom and adapted to affix to a portion of the perineal membrane ofthe patient on a second side of the urethra, opposite the first side ofthe urethra, and the second distal anchor device adapted to affix totissue away from the perineal membrane, such that the separated firstand second implant devices together form a general V-shaped supportconfiguration relative to the perineal membrane; and wherein tensioningadjustment on the first and second implant devices provides support forthe urethra to restore continence.
 28. The system of claim 27, whereinat least one of the first extension member and the second extensionmember includes a suture.
 29. The system of claim 27, wherein at leastone of the first extension member and the second extension memberincludes an elongate mesh.
 30. The system of claim 27, wherein the firstdistal anchor device includes a first array of anchors, each of thefirst array of anchors having expandable barbs and being operablyconnected to the first extension member.
 31. The system of claim 30,further including an introduction needle having a lumen extendingtherethrough, wherein at least the first array of anchors are adapted totraverse the lumen in a compressed state.
 32. The system of claim 27,wherein the second distal anchor device includes a second array ofanchors, each of the second array of anchors having expandable barbs andbeing operably connected to the second extension member.
 33. The systemof claim 27, wherein at least the first medial anchor device includesexpandable fins adapted to affix the first medial anchor device to theportion of the perineal membrane.
 34. The system of claim 27, wherein atleast one of the first distal anchor device and the second distal anchordevice is adapted to engage a target tissue site selected from the groupconsisting of: the obturator foramen, abdominal fascia, rectus fascia,the tendinous arch of the levator ani, the Cooper's ligament, and thepubic symphysis cartilage.
 35. The system of claim 27, wherein at leastone of the first medial anchor device and the first distal anchor deviceincludes an adhesive to assist in tissue engagement.
 36. The system ofclaim 35, wherein the adhesive is a light-activated adhesive.